Pharmaceutical Processing World

Companies currently in the tissue-based regenerative medicine business need to understand and comply with the FDA’s expectations for human cells, tissues and cellular and tissue-based product (HCT/P) under development in the next two years. HCT/P pertains to products containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If we are to jump…

In recent years, the discussion for flexible facility needs became widespread. The motivations for such flexible facility needs are manifold, for example, the requirement to rapidly deploy additional manufacturing capacities or scalability without interrupting existing processes. In addition, the transformation of the treatment or patient base to more personalized medicines necessitates the need to rethink…

The U.S. Food and Drug Administration have announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in…

Torrent Pharmaceuticals Limited is voluntarily recalling two lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs…